Cigarette Smoking-Related CarcinomaNCT06230159
Evaluating the Impact of Synthetic Cooling Agents in Combustible Cigarettes on Smoking Perceptions and Use
A study testing Non-menthol Cigarette Smoking, Menthol Cigarette Smoking and Synthetic Cooling Agent Cigarette Smoking in people with Cigarette Smoking-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial evaluates the impact of synthetic cooling agents in combustible cigarettes on smoking perceptions and use. Menthol, a natural chemical, is a cooling agent that increases nicotine dependence among smokers. Menthol cigarettes largely contribute to the huge burden that smoking puts on public health. Read more about this study
- Who is it for?
- Ages 21 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking-Related Carcinoma
- What is being tested?
- Non-menthol Cigarette Smoking, Menthol Cigarette Smoking and Synthetic Cooling Agent Cigarette Smoking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2023to 12 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 21 - 29 years
- Established cigarette user
- Willing to provide informed consent and abstain from using tobacco products 12 hours prior to the three lab sessions
- Read and speak English
Who cannot join
- Recently coronavirus disease 2019 positive (COVID-19+) or a recent COVID-19 hospitalization
- Self-reported unstable or significant psychiatric conditions
- History of cardiac event or distress within the past 3 months
- Are currently pregnant, planning to become pregnant, or breastfeeding
- Currently attempting to quit using combustible tobacco products
- Have suffered from any serious lung disease or infection in the past 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Synthetic Cooling Agents in Combustible Cigarettes: A Pilot Study
This clinical trial evaluates the impact of synthetic cooling agents in combustible cigarettes on smoking perceptions and use. Menthol, a natural chemical, is a cooling agent that increases nicotine dependence among smokers. Menthol cigarettes largely contribute to the huge burden that smoking puts on public health. Approximately 43% of adult smokers smoke menthol cigarettes. Regulatory agencies have begun a ban on menthol. In response to the ban, the tobacco industry has introduced synthetic cooling agents as a flavorless replacement to provide the same cooling effects as menthol. Information gained from this trial may help researchers determine how the addition of synthetic cooling agents changes the appeal, abuse liability potential, and respiratory toxicity profile of combustible cigarettes.
Read the detailed description
PRIMARY OBJECTIVES:
- Assess the content of synthetic cooling agents in newly introduced cooling agent non-menthol, menthol, and traditional non-menthol cigarettes.
II. Assess the subjective effects and abuse liability of cooling agent non-menthol cigarettes.
EXPLORATORY OBJECTIVE:
- Examine acute changes to pulmonary health associated with cooling agent cigarette use.
OUTLINE: Participants are randomized to use 1 of 3 cigarette conditions at 3 different study visits.
Participants participate in ad libitum smoking sessions with either a non-menthol control, menthol, or synthetic cooling agent cigarette condition once weekly (QW) over 3 weeks on study. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the study cigarette condition at the end of each study visit. Participants also undergo nasal swab collection over 5-10 minutes and spirometry and airwave oscillometry testing over 5-10 minutes pre- and post-smoking session at each study visit.
- Conditions
- Cigarette Smoking-Related Carcinoma
- Being tested
- Non-menthol Cigarette Smoking, Menthol Cigarette Smoking, Synthetic Cooling Agent Cigarette Smoking, Usual Brand Cigarette Smoking, Spirometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-menthol Cigarette SmokingBehavioural
Smoke a non-menthol cigarette
Menthol Cigarette SmokingBehavioural
Smoke a menthol cigarette
Synthetic Cooling Agent Cigarette SmokingBehavioural
Smoke a synthetic cooling agent cigarette
Usual Brand Cigarette SmokingBehavioural
Smoke usual brand cigarette
SpirometryDiagnostic test
Pulmonary function test
Questionnaire AdministrationOther
Survey questionnaires
Nasal Epithelial Lining FluidDiagnostic test
Nasal strip inserted into the nare to collect nasal epithelial lining fluid.
| Study group | Role | What they receive |
|---|---|---|
| Menthol cigarette | Active comparator | Participants participate in an ad libitum smoking session with a menthol cigarette for this condition. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the menthol study cigarette at the end of each study visit. Receives: Behavioral: Menthol Cigarette Smoking; Behavioral: Usual Brand Cigarette Smoking; Diagnostic Test: Spirometry; Other: Questionnaire Administration; Diagnostic Test: Nasal Epithelial Lining Fluid |
| Non-menthol cigarette | Active comparator | Participants participate in an ad libitum smoking session with a non-menthol control cigarette for this condition. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the non-menthol study cigarette at the end of each study visit. Receives: Behavioral: Non-menthol Cigarette Smoking; Behavioral: Usual Brand Cigarette Smoking; Diagnostic Test: Spirometry; Other: Questionnaire Administration; Diagnostic Test: Nasal Epithelial Lining Fluid |
| Cigarette with synthetic cooling agents | Active comparator | Participants participate in an ad libitum smoking session with a synthetic cooling agent cigarette for this condition. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the synthetic cooling agent study cigarette at the end of each study visit. Receives: Behavioral: Synthetic Cooling Agent Cigarette Smoking; Behavioral: Usual Brand Cigarette Smoking; Diagnostic Test: Spirometry; Other: Questionnaire Administration; Diagnostic Test: Nasal Epithelial Lining Fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarette Chemical Contents
Before participant recruitment began, chemical content analysis of 3 cigarettes of each study condition was performed. We used liquid-liquid extraction (LLE) to extract nicotine, WS-3, WS-23, and menthol from cigarette samples and quantified these analytes using gas chromatography-mass spectrometry (GC-MS).
Measured: Approximately 3 months prior to start of participant recruitment
Impact of Cooling Effects on Demand Via the Forced Choice Task
At each study visit, after the participant has smoked the study cigarette, the participant must choose between smoking the study cigarette again, or smoking one of their own, usual brand cigarettes. Within each arm, the proportion of participants who opt to continue smoking the study cigarette will be reported. This will measure if demand for the study cigarettes is great enough to overcome the desire for the participant's own preferred cigarettes.
Measured: After completion of study cigarette smoking session (Week 1, Week 2, Week 3)
Abuse Liability Via Puff Topography - Total Smoking Time
Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior. Greater frequency, duration, and flow rate of cigarette puffs suggest greater abuse liability.
Measured: During study cigarette smoking session (Week 1, Week 2, Week 3)
Abuse Liability Via Puff Topography - Average Puff Duration
Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior. Greater frequency, duration, and flow rate of cigarette puffs suggest greater abuse liability.
Measured: During study cigarette smoking session (Week 1, Week 2, Week 3)
Abuse Liability Via Puff Topography - Average Flow Rate
Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior. Greater frequency, duration, and flow rate of cigarette puffs suggest greater abuse liability.
Measured: During study cigarette smoking session (Week 1, Week 2, Week 3)
Abuse Liability Via Puff Topography - Average Inter-Puff Interval
Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior. Greater frequency, duration, and flow rate of cigarette puffs suggest greater abuse liability.
Measured: During study cigarette smoking session (Week 1, Week 2, Week 3)
Abuse Liability Via Puff Topography - Average Puff Volume
Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior. Greater frequency, duration, and flow rate of cigarette puffs suggest greater abuse liability.
Measured: During study cigarette smoking session (Week 1, Week 2, Week 3)
Cigarette Appeal
Participants will complete the Appeal and Sensory Quality questionnaire after smoking each study cigarette. This questionnaire will ask participants to rate each study cigarette for appeal characteristics such as liking, willingness to use again, flavor intensity, pleasantness of taste, etc. on a scale of 0 (not at all)-100(extremely). Higher scores indicate greater liking, willingness to use again, flavor intensity, etc.
Measured: Post study cigarette smoking session (Week1, Week 2, Week 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start28 Nov 2023
- Primary completion12 Jun 2024
- Study completion12 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cigarette Smoking-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Using a cross-over double-blinded study design, we will study the abuse liability (including sensory characteristics and appeal) of newly introduced cooling agent non-menthol cigarettes.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alayna Tackett, Ohio State University Comprehensive Cancer Center
- Investigators
- Alayna P Tackett, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230159
- Sponsor's protocol ID
- OSU-23208
- Other IDs
- NCI-2023-10761
- Status last verified
- Feb 2026
- First submitted
- 4 Jan 2024
- Last updated
- 3 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Niu Z, Miller L, Keke CM, Rings V, Hinton A, Nshimiyimana JD, Brinkman MC, El-Hellani A, Wagener TL, Tackett AP. Appeal, sensory characteristics and puffing topography of 'cool non-menthol' cigarettes among young adults who smoke: a randomised cross-over pilot trial. Tob Control. 2026 Jul 24:tc-2026-060118. doi: 10.1136/tc-2026-060118. Online ahead of print.
PubMed 42498634
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synthetic Cooling Agents in Combustible Cigarettes: A Pilot Study
- ClinicalTrials.gov ID
- NCT06230159
- Acronym / sponsor ID
- OSU-23208
- Conditions
- Cigarette Smoking-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 12 Jun 2024 (actual)
- First posted
- 30 Jan 2024 (actual)
- Results
- Posted 3 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial evaluates the impact of synthetic cooling agents in combustible cigarettes on smoking perceptions and use. Menthol, a natural chemical, is a cooling agent that increases nicotine dependence among smokers. Menthol cigarettes largely contribute to the huge burden that smoking puts on public health. Approximately 43% of adult smokers smoke menthol cigarettes. Regulatory agencies have begun a ban on menthol. In response to the ban, the tobacco industry has introduced synthetic cooling agents as a flavorless replacement to provide the same cooling effects as menthol. Information gained from this trial may help researchers determine how the addition of synthetic cooling agents changes the appeal, abuse liability potential, and respiratory toxicity profile of combustible cigarettes.
Detailed description
PRIMARY OBJECTIVES:
- Assess the content of synthetic cooling agents in newly introduced cooling agent non-menthol, menthol, and traditional non-menthol cigarettes.
II. Assess the subjective effects and abuse liability of cooling agent non-menthol cigarettes.
EXPLORATORY OBJECTIVE:
- Examine acute changes to pulmonary health associated with cooling agent cigarette use.
OUTLINE: Participants are randomized to use 1 of 3 cigarette conditions at 3 different study visits.
Participants participate in ad libitum smoking sessions with either a non-menthol control, menthol, or synthetic cooling agent cigarette condition once weekly (QW) over 3 weeks on study. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the study cigarette condition at the end of each study visit. Participants also undergo nasal swab collection over 5-10 minutes and spirometry and airwave oscillometry testing over 5-10 minutes pre- and post-smoking session at each study visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Using a cross-over double-blinded study design, we will study the abuse liability (including sensory characteristics and appeal) of newly introduced cooling agent non-menthol cigarettes.
| Arm | Type | Receives |
|---|---|---|
| Menthol cigarette | Active comparator | Behavioral: Menthol Cigarette Smoking, Behavioral: Usual Brand Cigarette Smoking, Diagnostic Test: Spirometry, Other: Questionnaire Administration, Diagnostic Test: Nasal Epithelial Lining FluidParticipants participate in an ad libitum smoking session with a menthol cigarette for this condition. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the menthol study cigarette at the end of each study visit. |
| Non-menthol cigarette | Active comparator | Behavioral: Non-menthol Cigarette Smoking, Behavioral: Usual Brand Cigarette Smoking, Diagnostic Test: Spirometry, Other: Questionnaire Administration, Diagnostic Test: Nasal Epithelial Lining FluidParticipants participate in an ad libitum smoking session with a non-menthol control cigarette for this condition. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the non-menthol study cigarette at the end of each study visit. |
| Cigarette with synthetic cooling agents | Active comparator | Behavioral: Synthetic Cooling Agent Cigarette Smoking, Behavioral: Usual Brand Cigarette Smoking, Diagnostic Test: Spirometry, Other: Questionnaire Administration, Diagnostic Test: Nasal Epithelial Lining FluidParticipants participate in an ad libitum smoking session with a synthetic cooling agent cigarette for this condition. Participants also participate in an ad libitum smoking session with either their usual brand cigarette or the synthetic cooling agent study cigarette at the end of each study visit. |
Who may qualify
- Ages
- 21 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 21 - 29 years
- Established cigarette user
- Willing to provide informed consent and abstain from using tobacco products 12 hours prior to the three lab sessions
- Read and speak English
Key exclusion criteria (6 listed)
- Recently coronavirus disease 2019 positive (COVID-19+) or a recent COVID-19 hospitalization
- Self-reported unstable or significant psychiatric conditions
- History of cardiac event or distress within the past 3 months
- Are currently pregnant, planning to become pregnant, or breastfeeding
- Currently attempting to quit using combustible tobacco products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-menthol Cigarette SmokingSmoke a non-menthol cigarette | Behavioural | Non-menthol cigarette |
| Menthol Cigarette SmokingSmoke a menthol cigarette | Behavioural | Menthol cigarette |
| Synthetic Cooling Agent Cigarette SmokingSmoke a synthetic cooling agent cigarette | Behavioural | Cigarette with synthetic cooling agents |
| Usual Brand Cigarette SmokingSmoke usual brand cigarette | Behavioural | Cigarette with synthetic cooling agents, Menthol cigarette, Non-menthol cigarette |
| SpirometryPulmonary function test | Diagnostic test | Cigarette with synthetic cooling agents, Menthol cigarette, Non-menthol cigarette |
| Questionnaire AdministrationSurvey questionnaires | Other | Cigarette with synthetic cooling agents, Menthol cigarette, Non-menthol cigarette |
| Nasal Epithelial Lining FluidNasal strip inserted into the nare to collect nasal epithelial lining fluid. | Diagnostic test | Cigarette with synthetic cooling agents, Menthol cigarette, Non-menthol cigarette |
Primary outcome
Cigarette Chemical Contents
Time frame: Approximately 3 months prior to start of participant recruitment
Before participant recruitment began, chemical content analysis of 3 cigarettes of each study condition was performed. We used liquid-liquid extraction (LLE) to extract nicotine, WS-3, WS-23, and menthol from cigarette samples and quantified these analytes using gas chromatography-mass spectrometry (GC-MS).
Impact of Cooling Effects on Demand Via the Forced Choice Task
Time frame: After completion of study cigarette smoking session (Week 1, Week 2, Week 3)
At each study visit, after the participant has smoked the study cigarette, the participant must choose between smoking the study cigarette again, or smoking one of their own, usual brand cigarettes. Within each arm, the proportion of participants who opt to continue smoking the study cigarette will be reported. This will measure if demand for the study cigarettes is great enough to overcome the desire for the participant's own preferred cigarettes.
Abuse Liability Via Puff Topography - Total Smoking Time
Time frame: During study cigarette smoking session (Week 1, Week 2, Week 3)
Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior. Greater frequency, duration, and flow rate of cigarette puffs suggest greater abuse liability.
Abuse Liability Via Puff Topography - Average Puff Duration
Time frame: During study cigarette smoking session (Week 1, Week 2, Week 3)
Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior. Greater frequency, duration, and flow rate of cigarette puffs suggest greater abuse liability.
Abuse Liability Via Puff Topography - Average Flow Rate
Time frame: During study cigarette smoking session (Week 1, Week 2, Week 3)
Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior. Greater frequency, duration, and flow rate of cigarette puffs suggest greater abuse liability.
Abuse Liability Via Puff Topography - Average Inter-Puff Interval
Time frame: During study cigarette smoking session (Week 1, Week 2, Week 3)
Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior. Greater frequency, duration, and flow rate of cigarette puffs suggest greater abuse liability.
Abuse Liability Via Puff Topography - Average Puff Volume
Time frame: During study cigarette smoking session (Week 1, Week 2, Week 3)
Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs. These measures are combined to inform overall cigarette puff behavior. Greater frequency, duration, and flow rate of cigarette puffs suggest greater abuse liability.
Cigarette Appeal
Time frame: Post study cigarette smoking session (Week1, Week 2, Week 3)
Participants will complete the Appeal and Sensory Quality questionnaire after smoking each study cigarette. This questionnaire will ask participants to rate each study cigarette for appeal characteristics such as liking, willingness to use again, flavor intensity, pleasantness of taste, etc. on a scale of 0 (not at all)-100(extremely). Higher scores indicate greater liking, willingness to use again, flavor intensity, etc.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42498634Niu Z, Miller L, Keke CM, Rings V, Hinton A, Nshimiyimana JD, Brinkman MC, El-Hellani A, Wagener TL, Tackett AP. Appeal, sensory characteristics and puffing topography of 'cool non-menthol' cigarettes among young adults who smoke: a randomised cross-over pilot trial. Tob Control. 2026 Jul 24:tc-2026-060118. doi: 10.1136/tc-2026-060118. Online ahead of print.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alayna P Tackett, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-menthol Cigarette Smoking, Menthol Cigarette Smoking and Synthetic Cooling Agent Cigarette Smoking in people with Cigarette Smoking-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cigarette Chemical Contents (time frame: Approximately 3 months prior to start of participant recruitment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06230159, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.